Our vaccine solution

Combination vaccines are increasingly a cornerstone of infant immunization programs.

MCM partnership objective

Was to leverage the extensive expertise of MSD and Sanofi Pasteur to develop a combination vaccine that uses antigens from both companies(1-2).

MCM Vaccine has developed a 6-in-1 vaccine indicated for the primary and booster vaccinations from the age of six weeks, against diphtheria, tetanus, pertussis (whooping cough), hepatitis B, poliomyelitis and diseases caused by Haemophilus type b (Hib)(3).

The European Medicines Agency granted marketing authorization for this vaccine, under the brand name of Vaxelis® - diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated), and Haemophilus influenzae type b conjugate vaccine (adsorbed) - in February 2016(4).

Please read the full information about the product posted here.

US FDA granted marketing authorization for this vaccine, under the brand name of Vaxelis®, in December 2018(5).

Swissmedic granted marketing authorization for this vaccine, also under the brand name of Vaxelis®, in August 2019(6). The MAH in Switzerland is FutureHealth Pharma GmbH.

Australian TGA granted marketing authorization for this vaccine, also under the brand name of Vaxelis®, in March 2022(7).

For United Kingdom, the EU/EEA marketing authorisation of Vaxelis has been converted into an United Kingdom marketing authorisation effective in Great Britain since 1 January 2021(8).

For additional information, please consult your health care provider.

Diphtheria

Diphtheria is a highly contagious disease caused by the bacterium Corynebacterium diphtheria, which produces a toxin that can affect the throat and skin, and can cause damage to the heart and other organs and death(9).

TETANUS

Tetanus is a serious disease caused by the bacterium Clostridium tetani, which produces a toxin that affects the body's muscles and nerves and can cause death. Usually the bacterium infects the body through a wound(10).

Pertussis (whooping cough)

Pertussis is a highly contagious bacterial infection of the respiratory tract which can cause serious illness in infants, including death(11).

Hepatitis B (Hep B)

Hep B is a viral infection of the liver and can cause cirrhosis, primary liver cancer and death(12).

Poliomyelitis (Polio)

Polio is a highly infectious disease caused by the poliovirus, which affects the nerves and can lead to muscle weakness or paralysis or death(13-14).

Haemophilus type b (Hib) diseases

Hib is a bacterium that can cause severe invasive diseases in infants, such as meningitis, with neurologic sequelae and death(15).

MCM partnership objective

Was to leverage the extensive expertise of MSD and Sanofi Pasteur to develop a combination vaccine that uses antigens from both companies(1-2).

MCM Vaccine has developed a 6-in-1 vaccine indicated for the primary and booster vaccinations from the age of six weeks, against diphtheria, tetanus, pertussis (whooping cough), hepatitis B, poliomyelitis and diseases caused by Haemophilus type b (Hib)(3).

The European Medicines Agency granted marketing authorization for this vaccine, under the brand name of Vaxelis® - diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated), and Haemophilus influenzae type b conjugate vaccine (adsorbed) - in February 2016(4).

Please read the full information about the product posted here.

US FDA granted marketing authorization for this vaccine, under the brand name of Vaxelis®, in December 2018(5).

Swissmedic granted marketing authorization for this vaccine, also under the brand name of Vaxelis®, in August 2019(6). The MAH in Switzerland is FutureHealth Pharma GmbH.

Australian TGA granted marketing authorization for this vaccine, also under the brand name of Vaxelis®, in March 2022(7).

For United Kingdom, the EU/EEA marketing authorisation of Vaxelis has been converted into an United Kingdom marketing authorisation effective in Great Britain since 1 January 2021(8).

For additional information, please consult your health care provider.

(1) European Medicines Agency (EMA): Assessment report VAXELIS. https://www.ema.europa.eu/en/documents/assessment-report/vaxelis-epar-public-assessment-report_en.pdf Lastaccessed June 2022).

(2) Andrew W. Lee, Emilia Jordanov, Florence Boisnard & Gary S. Marshall (2017) DTaP5-IPV-Hib-HepB, a hexavalent vaccine for infants and toddlers, Expert Review of Vaccines, 16:2, 85-92, DOI: 10.1080/14760584.2017.1268920.

(3) VAXELIS SmPC. European Medicines Agency [EMA].
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003982/WC500202435.pdf (Last accessed June 2022).

(4) European Medicines Agency (EMA). EPAR summary for the public. Vaxelis. 2016. Sourcedat: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_Summary_for_the_public/human/003982/WC500202438.pdf (Lastaccessed June 2022).

(5) U.S Food & Drug Administration (FDA). Approval Letter – VAXELIS. 2018. Sourced at https://www.fda.gov/media/119466/download (Last accessed June 2022).

(6) Swissmedic. Vaxelis®, Injektionssuspension in einer Fertigspritze. Availableat: https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/authorisations/new-medicines/vaxelis_injektionssuspension_fertigspritze.html (Last accessed June 2022).

(7) Australian Government, Department of Health and Aged Care, Therapeutic Goods Administration (TGA). Australianprescription medicine decision summaries – VAXELIS. 2022. Sourced at https://www.tga.gov.au/apm-summary/vaxelis (Last accessed June 2022).

(8) GOV.UK. Marketing authorisations, variations and licensing guidance. 2020. Sourced at https://www.gov.uk/guidance/converting-centrally-authorised-products-caps-to-uk-marketing-authorisations-mas-grandfathering-and-managing-lifecycle-changes (Last accessed June 2022).

(9) Centers for Disease Control and Prevention (CDC). Epidemiology and Prevention of Vaccine-Preventable Disease. Diphtheria. Hamborsky J, Kroger A, Wolfe C, eds. 13th ed. Washington, DC. Public Health Foundation. 2015;107-118. https://www.cdc.gov/vaccines/pubs/pinkbook/downloads/dip.pdf (Last accessed June 2022).

(10) CDC. Epidemiology and Prevention of Vaccine-Preventable Disease. Tetanus. Hamborsky J, Kroger A, Wolfe C, eds. 13th ed. Washington, DC. Public Health Foundation. 2015;341–351 https://www.cdc.gov/vaccines/pubs/pinkbook/downloads/tetanus.pdf (Last accessed June 2022).

(11) CDC. Pertussis (Whooping cough). https://www.cdc.gov/pertussis/about/photos.html. (Last accessed June 2022).

(12) WHO. Hepatitis B vaccines. WHO position paper. Wkly Epidemiol Rec. 2009;84(40):405–420. 

(13) WHO. Polio vaccines: WHO position paper, March 2016. Weekly epidemiologcal record (WER), 2016; 91:145-168. 

(14) WHO. Poliomyelitis - Fact sheet N°114, sourced at: http://www.who.int/mediacentre/factsheets/fs114/en/, (Last accessedJune 2022).

(15) Natonal Health Service (UK). Haemophilus influenzae type b (Hib), sourcedat: http://www.nhs.uk/conditions/hib/pages/introduction.aspx, (Last accessed June 2022).